Zinc Deficiency
Conditions
Brief summary
The general objective of this study is to determine the effect of the daily consumption of zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school age children from rural areas characterized by a high risk of zinc deficiency and by elevated stunting prevalence.
Detailed description
A double-blind efficacy study will be carried out over 4 months in school age children enrolled in a primary school equipped with a water pump, in the rural area of the commune of Natitingou, Benin. Participating children will be randomly assigned to one of two groups of intervention or control. On a daily basis, all children will consume a defined quantity of pump-water outside of meals. The water offered to children in the first group of intervention will be previously filtered and zinc-fortified by the LSF-filter; the children in the second group will receive water that has been filtered only. A nutrition survey will provide an indication of dietary zinc intake. The effect of enriched water consumption on children's zinc status will be evaluated by analyzing the concentration of zinc in serum at baseline, midpoint and endpoint of the intervention. Diarrhea rates will be monitored by recording episodes of diarrhea.
Interventions
DEVICELSF-filtering device
LifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (\<0.5 NTU turbidity reduction), bacteria (\>Log 6 reduction), viruses (\>Log 4 reduction) and cysts (\>Log 3 reduction). Zinc fortification is provided by a chamber housing a zinc releasing glass-plate that is placed annexed to the hollow fibre column. It is estimated that the LSF can provide about 5 mg of zinc/l of filtered water. By consuming daily a portion of 0.6 litres of enriched water, \>100% of the age-specific estimated physiologic requirement would be covered, assuming a fractional absorption of 40%.
Sponsors
Université d'Abomey-Calavi
Prof. Michael B. Zimmermann
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 10 Years
Healthy volunteers
Yes
Inclusion criteria
* School aged children enrolled in primary school and regularly attending class
Exclusion criteria
* Severe anemia (Hb \< 7 g/dl) * Consumption of a supplement or dietary supplement containing zinc * Use of drugs that affect the metabolism of zinc * Suffering from a chronic disease affecting the metabolism of zinc
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zinc status | Baseline, midpont (varying between weeks 5-20), endpoint (week 22) | Serum zinc concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Iron status | Baseline, midpoint (varying between weeks 5-20), endpoint (week 22) | Haemoglobin level |
| Diarrhea incidence | Weekly, from baseline through to endpoint | Occurrence of diarrhea episodes monitored over 2 days weekly |
| Inflammation status | Baseline, midpoint (varying between weeks 5-20), endpoint (week 22) | Concentration of CRP in serum |
| ALRI prevalence | At baseline and endpoint | Auscultation and respiratory frequence (no. of chest movements per minute) |
| Anthropometric indices | Baseline, midpoint (varying between weeks 5-20), endpoint (week 22) | Measurement of height, weight and mid-upper arm circumference for the assessment of height-for-age, weight-for-age and BMI-for-age Z-scores. |
| Malaria prevalence | Baseline, midpoint (varying between weeks 5-20), endpoint (week 22) | Screening of HRP-II antigen |
Countries
Benin
Outcome results
None listed